MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number	60PFS45
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend plus.Manufacturer mislabeling of trachs.Outside and inner box says v flange but they were straight flange.A straight flange was placed on a patient.Four more were found with the same issue.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A device history record review (dhr) was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four images and three samples were received for evaluation.Visual inspection was performed at 12 under normal lighting to received unit, to detect any damage on the cuff, airline or pilot balloon.During the visual inspection, it was observed that products inside the trays don't match labelling, labeling is for a product with a v flange and the product inside the tray has a straight flange.The complaint is confirmed.Based on the root cause analysis of corrective and preventative action (capa), the following causes were identified and categorized as follows: the super slick process" and procedure, cleaning / vacuum oven / super slick was updated to document the use of containers to place the material documentation (dhr and bin tags) while the materials are in the oven process.The visual aid for sealing inspection for sealing inspection for bivona was updated to add the visual guidance for tray sealer process.Lastly, the training process to identify physical parts with part numbers was implemented per procedure, quality system training execution.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record review (dhr) was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four images and three samples were received for evaluation.Visual inspection was performed at 12 under normal lighting to received unit, to detect any damage on the cuff, airline or pilot balloon.During the visual inspection, it was observed that products inside the trays don't match labelling, labeling is for a product with a v flange and the product inside the tray has a straight flange.The complaint is confirmed.Based on the root cause analysis of corrective and preventative action (capa), the following causes were identified and categorized as follows: the super slick process" and procedure, cleaning / vacuum oven / super slick was updated to document the use of containers to place the material documentation (dhr and bin tags) while the materials are in the oven process.The visual aid for sealing inspection for sealing inspection for bivona was updated to add the visual guidance for tray sealer process.Lastly, the training process to identify physical parts with part numbers was implemented per procedure, quality system training execution.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12221803
• Report Number: 3012307300-2021-07603
• Device Sequence Number: 16491533
• Product Code: JOH
• UDI-Device Identifier: 15021312005875
• UDI-Public: 15021312005875
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2025
• Device Model Number: 60PFS45
• Device Catalogue Number: 60PFS45
• Device Lot Number: 3991171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 02/21/2023; 02/21/2023
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 02/08/2023; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown